Trials / Completed
CompletedNCT05827588
Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
A Prospective, Single-arm Study to Evaluate the Feasibility of Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) in Subjects With End-Stage Kidney Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- AWAK Technologies Pte Ltd · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this late feasibility clinical trial is to evaluate the safety and effectiveness of the Automated Wearable Artificial Kidney (AWAK) peritoneal dialysis (PD) device in subjects with end-stage kidney disease. The main questions it aims to answer are: * the success of AWAK PD therapies when used in a home-setting * the safety and effectiveness of the AWAK PD system Participants will: * be titrated to find a suitable AWAK PD prescription * be trained on how to use the AWAK PD system independently * use the AWAK PD system at home for at least 7 days
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AWAK PD | Daily 7- or 9-hour therapy (with or without a last fill) that is a form of automated peritoneal dialysis being done by subjects who are already on daily PD therapy |
Timeline
- Start date
- 2023-03-31
- Primary completion
- 2024-03-10
- Completion
- 2024-07-29
- First posted
- 2023-04-25
- Last updated
- 2024-07-31
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT05827588. Inclusion in this directory is not an endorsement.